ES2436590T3 - Embolic braid ball devices and placement systems - Google Patents

Abstract

A detachable implant pusher system (330) comprising: an implant (10, 40, 60, 62, 64, 70, 72, 140, 300, 342) that includes a proximal port section (276); an elongated pusher sleeve (338); and a plurality of elongate members (332, 336) received within a light of the pusher sleeve, which exits at proximal and distal ends, and elongated members are received through the implant port, where the sleeve is locked to the implant until that at least one elongated member be taken inside the sleeve; characterized in that one of the elongate members (336) includes an end of the extended terminal located outside the port section; and wherein the other elongated member (332) includes an enlarged end.

Description

Embolic braid ball devices and placement systems

BACKGROUND

The dominant clinical trend in the endovascular treatment of intracranial aneurysms has changed little since the use of vasoocclusive spiral was extended in the 1990s. Certainly, improvised catheters and other auxiliary devices (for example, the stent) have helped make spiral placement procedures safer and / or more effective. However, the technique to achieve a suitable and appropriate aneurysm spiral packing is the most performed by the most specialized doctors.

Where possible, exclusion of the aneurysm by means of covering devices may be preferred (for example, described in US Patent Application No. 12 / 397.123 to the assignee thereof). Certain other groups are trying to divert the idea of the intraaneurysm spiral packing to achieve embolization by deploying a stent / diverter stent to the flow of an extraaneurysm in the main vessel. These densely braided devices and / or multiple braid devices layered on each other are located in the main vessel along the neck of an aneurysm in order to alter the hemodynamics to effect embolization.

These devices similar to a vascular stent are the most suitable for placement along aneurysms of the lateral wall. In addition, terminal aneurysms (for example, bifurcation aneurysms) are estimated by some that cause approximately 60% to 80% of all aneurysm occurrences. In a more optimistic calculation only about 40% of intracranial aneurysms can be treated by using mentioned devices similar to vascular stents.

Numerous other devices have been designed to treat terminal aneurysms. Complicated and / or impracticable deployment is common in many cases. Others simply serve as complementary to spirals or liquid embolic agents. In these latter examples the procedures can become more complicated and require even greater physician skill than in a normal spiral procedure.

A simpler and more promising solution is the proposal in document PCT / US 2007/0076232 by Dieck and others. A conical braiding / mesh member is described to divert blood flow from the aneurysm neck. A base of the device is placed inside the aneurysm while a diverting part of the flow extends into the main vessel to direct the blood flow to the adjacent lateral branches and away from the aneurysm. The implant can be placed inside the aneurysm as an independent device or be supported by a connected stent-like body.

USP Nos. 6,168,622 and 6,506,204 of Mazzochi et al. Describe another type of twisted flow switch placed at least partially within an aneurysm. A bulbous part is adapted to fit inside the aneurysm cap and is anchored on the outside by a fin that covers the neck. Given the way in which bifurcation aneurysms often incorporate the anatomy of the secondary vessel, such a patch would often interfere with and / or the free "fin" causing significant problems of potential thrombus formation within the main vessel.

EP 1,621,148 A1 describes a deployment system of a vasoocclusive embolic device for use in placing an embolic device in a predetermined place within a vessel. An elongated flexible catheter has a lumen that extends along it and has proximal and distal ends. An elongated pusher member has proximal and distal ends and is slidably disposed within the lumen of the catheter. An embolic device has a plurality of turns that releasably engage the distal end of the pusher member. A separation filament extends from a proximal position of the proximal end of the catheter through the lumen of the catheter and about one turn of the embolic device. When the embolic device is properly placed in a predetermined place within the vessel, the separation filament can be pulled proximally to disengage the separation filament from the return of the embolic device to thereby release the embolic device at the predetermined place.

US 2007/221230 A1 describes a lung volume reduction system comprising an implantable device adapted to be placed in a patient's lung airway in a placement configuration and to change to a deployed configuration to bend the pathway. respiratory lung The implantable device has an elastically curved placement configuration and the deployed configuration has a rigid shape. The system further comprises an actuator adapted to be operated from outside the patient to change the implantable device from the placement configuration to the deployed configuration. The actuator comprises a drive element connected to a distal end of the implantable device and adapted to be moved proximally to bend the device and a lock to lock the device in the deployed configuration.

SUMMARY OF THE INVENTION

In accordance with the present invention, the removable implant pusher system of claim 1 has been provided.

Next, wire braid ball implants for occlusion of blood flow in endovascular sites are described and illustrated, as well as the placement systems and methods of making the balls. The balls are useful for the treatment of neurovascular defects. One use is in the embolization / occlusion of intracranial aneurysms and another is in the occlusion of the main vessel (PVO) or its sacrifice.

Generally speaking, the exposed vascular implants are braided devices that use a combination of biostable materials selected from Stainless Steel, Cobalt Chromium, Nitinol, Titanium, Titanium Alloys, Zirconium and Zirconium Alloys, PET (or other suture material) and of medical grade adhesives. The density of the device is capital in applications where the braid itself is intended to affect the flow of blood, which allows thrombosis within a volume formed by the ball to occlude a place. Thus, a high braid / mesh density is usually required. That is, a braid having at least about 48 ends, normally placed at about 90 degrees or more, can be used in diameters of about 4 to 8 mm. With larger diameters (for example, about 6 mm to 12 mm or more), more wire ends (for example, common multiples of 64, 72, 96, 128, 144) can be used to form the balls. Normally larger amounts of wires can also be used. Any of the commercially available standard 192 and 288 support braiding machines can be used. Three-dimensional braiding technology (such services are provided by 3Tex, Inc) can also be used for the formation of the braid matrix from which the balls are formed. In addition, any combination of wire diameters, wire quantity, braid angle, and crosses per inch can be used to make the braid in order to configure an occlusive device of blood flow deemed appropriate for a particular vascular site.

A range of wire sizes or a combination of wire sizes, typically ranging from about 0.0008 (0.02 mm) to about 0.0015 inches (0.04 mm), and up to about 0.003 inches ( 0.08 mm) depending on the desired placement profile (which is typically desired to be less than about 0.050 inches (1.3 mm) - at least for neurovascular indications and more generally up to about 0.070 inches (1.8 mm) for indications of Peripheral PVO). A single braid tube may have all wires of the same diameter, or it may have some wires with a slightly thicker diameter to give additional strength to the braid layer. For example, half of the wires of a 96-wire tube (ie 48 ends) can have for example a diameter of 0.001 "(0.025 mm) and the other half of the wires can have a diameter of, for example, 0.0015 ”(0.04 mm). In this case the two wire sizes could typically be intertwined evenly to form the braid. The thicker wires give greater resistance to the braid without significantly increasing the positioning profile of the device, with the thinner wires offering some resistance while completing the density of the braid matrix.

The wire is preferably of a NiTi alloy that is superelastic at body temperature. The metal can be a binary alloy or a ternary alloy to provide additional radiopacity. Alternatively, radiopaque platinum fibers may be included in the braid, or the wire may comprise a Nitinol DFT or a platinum or gold core. Otherwise, bushings, bands or windings (preferably of Pt) used to fix the braid wire (at either or both distal and proximal ends), and also between the caps where convenient) may serve as the only radiopaque element or elements.

To improve the corrosion resistance of the implant wire and / or the biocompatibility resistance after thermal fixation of the shape, the implants can be etched in a solution of "AYA" Sulfamic Acid, then passivated in a Nitric Acid solution. . Alternatively or additionally, the prerecorded and / or polished wire can be used in braiding the implant matrix. The fixation of the shape of the braid in the shape of the implant can be done in an oven / oven, in a fluidized bath or in a pot with salt. This whole process is within the knowledge of people with a normal experience in the art.

Especially after thermal fixation of the form, the wire can be coated with an agent to facilitate a desired biological effect. For example, the wire can be coated with a thrombogenic agent or an endothelializing agent, or another agent capable of promoting a desired biological process in the intended place. The braid balls may also be partially or fully coated on the outside (for example, with a coating such as urethane) to increase the occlusive effect of the ball, provided that the coating does not cause the placement profile of the final device does not exceed Allowed limits Hydrogel coating also offers an attractive option, such as a polymer network with a hydrogel base capable of trapping therapeutic agents, described in USPN 6,905,700 to Won et al.

Similarly, while the balls advantageously comprise a Nitinol braid, the braid may instead comprise a polymer - especially a high strength biodegradable polymer such as MX-2 (MAX-Preno), a synthetic absorbable monofilament (90 / 10 Glycolide / L-Lactide) and / or G-2 (Glycoprene), a monofilament

synthetic absorbable (Glycolide (PGA), ε-Caprolatone (PCL), a copolymer of Trimethylene Carbonate (TMC)) that thermally sets its shape (for example, at 110 degrees Celsius in one hour).

The ability to place exposed implants in certain neurovascular sites (for example, distal intracranial aneurysms) often requires that they be compressible to pass through a sized catheter to navigate the narrow, tortuous vessels of the brain. Normal neurovascular catheters suitable for such use have lumen diameters of 0.021 "(0.5mm) and 0.027" (0.7mm). Commercially available microcatheters may be preferred for balls of wire quantities greater than 0.027 "(0.7 mm) ID (for example, Cordis Mass Transit Boston Scientific Renegade HI-FLO) or greater (for example Concentric Merci Distal Access Catheter ID of 0.044 "(1.1mm)). For devices adapted to respond to PVO indications in which larger amounts of wire or larger wire diameters are used to fix the anchor, the implants may require 5 and / or 6 Fr guide catheters for placement.

In some of the described configurations the devices can comprise a high density Nitinol braid that is folded / folded back on itself and thermally fixed to provide an open body that has two contiguous layers that form an even denser matrix to occlude the blood flow The section folded back (inverted or turned outward) can be closed to define a distal end of the device in which a radiopaque element can be placed. On the opposite side of the implant braid filaments are attached in a bushing that includes at least one outer band.

A port within the hub can receive one or a few components of an optional separable pusher. Alternatively, the implant can be deployed through a catheter by using a single pusher. The strands of the braid inside the bushing or bushings can be welded together and / or with the band. Alternatively, the braid and the bushing (s) may be fixed using a biocompatible adhesive.

In a relaxed state, the implants define an open volume, preferably rounded. In a placement catheter they compress to form a substantially cylindrical body. When deployed at a treatment site, they expand to make contact with the surrounding tissue and occlude the flow in a clinically interesting period of time.

The use of a separable pusher favors the deployment of a device (for example, in an aneurysm) and the adjustment check. Deployed in an aneurysm to occlude the aneurysm in its neck, the implant device largely adopts the aneurysm shape, with the proximal bushing and the adjacent braid material very close outside the neck. To achieve such an adjustment, the implants are arranged in a range of sizes. These can advance with increases in diameter from 0.5 mm to 1 mm. For the treatment of the aneurysm in the bifurcations it may also be desirable that the ball (at least in its placed configuration) adopts a tear shape to assist in a flow-divider / diverter type function described in Dieck et al., Mentioned above.

However, if the selected implant does not fit the desired shape, it could simply be removed inside the placement catheter. If the desired setting is achieved (with the first implant or with a replacement) confirmed by viewing medical images, the implant is released.

An electrolytically releasable GDC type seal can be used to keep the implant attached to the pusher until it is released. Details regarding suitable electrolytic separation systems can be appreciated and applied to the current system described in Guglielmi document USPN 5,122,136 and the following requests thereto. Another electrically activated separation method uses a fiber bond or fusible suture that connects the implant with the pusher / positioning guide. In such a system a polymer core can be configured with helically wound conductive strips attached to the core. After applying a voltage, a sufficient current is sent through the tapes to a wire bridge that connects them. The heat generated along the bridge, optionally a Chrome Nickel wire, cuts the suture that is attached to or is adjacent to the bridge in order to release the implant. Additional details of a molten suture separation system are described in the interim applications incorporated.

Even so, mechanical separation systems may be the most preferred. One aspect of the present description involves pushers in which at least one member provides mechanical interference in / with the port of the implant bushing so as to releasably block the implant on the pusher. In one method a wire or tape that exits an extension of the threaded pusher through the port produces such interference until it is removed. In another example a plurality of wires / tapes are received through the port. One or more (typically two or three) of these wires extend through the body of a pusher catheter to an interface of a proximal handle. A final "anchor" wire received through the port can also extend to the handle. The anchor wire includes a head sized to exit the bushing port only after the "control" wires have been removed there. The head is preferably formed by a laser or thermal / fusion plasma. The handle provides a user interface to first remove the control wires, and then (optionally) also pull the final anchor wire.

To aid in the recapture of an implant in case it is not released, a smooth recapture profile with an introduction / trumpet form may be disposed between the bushing and the main body of the implant. In another relevant method in a two-layer implant such a profile is not arranged. Rather, only the outer part of the braid layer is fixed inside the bushing, and the inner layer "floats." In this way only the outer layer has to be straightened in relation to the bushing to recover the ball inside the catheter / sheath, with the inner layer running along it.

In order to allow such action the braid matrix has to remain stable and interlocked. Consequently, when possible, a braid model will be preferred over one another. In addition, the braid should be trimmed adjacent to the bushing, where the braid attached to the bushing is denser. Thus configured, the outer braid serves as a guide and is of such density to prevent the loose ends of the inner layer from protruding through it. While a floating layer type ball implant would typically only be used for an aneurysm indication due to reduced radial resistance, the recapture profile can be used either in an aneurysm implant or for PVO use.

Apart from the recapture elements, when they are deployed in a vessel for use in the occlusion of a main vessel, the exposed implant has a "sausage" shape. For such purposes it may be convenient that the compressed length of the ball be minimized relative to its diameter. The proximal and / or distal ends of the ball may be flattened or flatter (so that the ball has a shape more like a "donut") for this purpose.

The oversizing of the device relative to the vessel provides adequate radial force to anchor its position against blood flow / pressure. To generate more anchoring force within a vessel for a specialized PVO implant (i.e., of a given deployed length), the ball has to be formed with a profile so that it has an elliptical straight section. To offer a more improved anchorage of the vessel, a cylindrical belt can be incorporated into the shape. The formed edges will concentrate the efforts on the vessel wall in some cases to improve anchoring. Even so, the profile size allows the implant to work within a wide range of vessel sizes. Certainly, a size can be adjusted over a wide range of vessel diameters (for example, a 10 mm ball suitable for 3-5 mm vessels, etc.).

In one or another type of implant (ie, aneurysm or PVO) an advantageous construction involves folding or folding back the braid during manufacturing to produce a two-layer matrix. A central fold or crease is formed in the braid, which is used to define one end of the implant.

The fold may be preset in the braid or formed in the braid fastener to fix its shape. In the previous case, the curvature is preset by the thermal fixation of the braid when it is confined in a very tight tubular shape (for example, by a corrugator or at least partially inside a hypotube). In the latter case the braid is tied with a suture at one point, a shape is inserted into the open end of the braid tube and the braid is stretched, or placed, over the shape with the folded section subjected to compression. When heated to fix the profile, the suture burns and disappears as the compression force sets the crease to a minimum radius.

The fold itself is useful in several cases. In a variant of the invention, the folded section provides a non-traumatic end of the implant. The folded section can be left open, or linked closed by a suture, a loop of wire (or other material). If it is not radiopaque itself, the ligation can also hold a marker band (knotted, glued or wavy). If such a marker is provided, it can advantageously be suspended adjacent to the upper / distal end of the ball within the interior volume.

In one case or another, after compression to a placement profile, the implant body basically pivots (rather than bends) in the fold, and thus the forces in the catheter / sheath are minimized. This improves the ability to track the device as well as the placement and the ability to recapture it if treatment with a device of another size is desired.

In a specific PVO implant, a marker band can be attached between the braid layers adjacent to the central fold. The band is captured safely and "hidden" without showing edges or other elements. As such, the distal end of the device offers a smooth positioning / tracking profile without the need to fix the band.

Used in any of such ways (ie, open, bound or with a band), at one end of the ball joints and other elements that increase the placement profile are avoided. In this way the fold offers constructive advantages (which include the possibility of improved manufacturing) as well as the reduction of the areas of failure where the ends of the braid would otherwise need to be secured. In addition, the tubular laminated material folded back reaches an excellent density while ensuring uniform compression and a resilience of shape since the layers are well matched. Thus paired, they extend / shorten to a substantially equal degree when they exit and re-enter the catheter.

A variant of the invention takes advantage of the paired braid layers, and simply removes the crease by grinding or otherwise trimming it after thermal fixation (and, optimally, fixing the braid bushing). Thus prepared, the implant becomes more radially adaptable as may be desirable for treatment.

of aneurysm And without any additional space occupied by the curvature in the filaments the ball can also be compressed for placement through the smaller microcatheters (for a given braid density) to gain access to the most distal treatment sites.

Another variant of the invention may or may not be constructed by a backward bending method. To achieve higher braid densities without stacking additional layers that have to fit within the lumen of the microcatheter, however, additional "cap" structures can be incorporated into the implant. For placement, these elements are narrowed down or compressed in series. However, after the exit of the microcatheter, they recover a position adjacent to the main body of the implant.

The ball body and the cap parts of the implant are typically constructed from a continuous braid section. The intermediate sections of the marker can be arranged between the elements. A bushing that includes a port of the positioning system is disposed at the proximal end of the device.

Proximal braid caps provide additional braid layers to the device at one end where blood flow occlusion is critical. The proximal end of a ball located in an aneurysm makes contact with the opening and neck of the aneurysm. To achieve greater flow occlusion the braid caps can be a single or double layer braid. One or more braid caps can be placed at the proximal end of the ball (that is, a braid ball can have up to three braid caps, and more if possible).

Braid caps do not work, and are not adapted to work, as anchors for the device. An anchor firmly holds or checks the movement of an object attached to it. To anchor something you have to fix or hold, or firmly adhere an object. Ball implants are not anchored in the aneurysm or main vessel by braid caps. Rather, braid caps are designed to be adjacent to the ball inside an aneurysm or to fill only the neck area. In any case, the caps are not substantially applied to the vascular tissue adjacent to the ball. They serve as occlusive elements that increase the embolic potential of the ball.

As mentioned, two types of braid ball implants with caps are arranged. Caps adapted to fit only on the aneurysm neck are typically round (although they can be oval) and can be offered in a variety of sizes to fit with different neck sizes precisely when the ball portion of the implant is offered in different sizes. In other words, along a complete line of implants, each of the parameters of the size of the cap and the size of the ball can be varied.

The caps adapted to fit in an aneurysm adjacent to the ball part of the implant are larger and with a shape to conform to the ball-shaped body. Its placement requires compressing the ball portion of the implant into the aneurysm and unfolding the cap on it, or deploying the cap outside the aneurysm and pushing it into the aneurysm in an unfolded state.

The placement of the devices with the neck filling caps or discs is carried out substantially the same as the balls without such or such elements with the exception that the placement catheter is subsequently removed to expose the cap (s), or the catheter It is parked outside the neck of the aneurysm (instead of in the neck) and the implant is extruded from it. Of course, some combination of such activity can alternatively be used.

In any case, if the desired setting has been achieved, the implant is released. Otherwise, the implant is pulled into the placement catheter from the proximal bushing. The one or more caps are compressed until the linear profile of the placement / recovery sheath is achieved, followed by the part of the ball.

In yet another variant of the invention a braid ball is used in conjunction with a stent. The ball can be attached to a stent, placed in conjunction with it. Alternatively, a frame or box can be arranged at the end of a stent inside which a braid ball is placed after the stent is in place. In any case, the ball and / or the frame can be sized to substantially fill the entire aneurysm or just fill the neck. In any case, the stent will serve as an anchor to prevent the ball from leaving. The solution of the frame plus the ball offers certain advantages in terms of the possibility of gradual placement, while the stent with the ball at the top offers a simple solution that can be achieved in a single placement. In each example, the stent can be self-expanding (for example, comprising superelastic Nitinol) or expandable ball (for example, comprising stainless steel and mounted on a PTCA type ball). In spite of everything, the braid ball implant used can be any of those described in this filling or those mentioned above.

The present invention includes the exposed devices and assemblies in which the methods of use and manufacturing are included. Several aspects of such manufacturing have been discussed before. A more detailed discussion is presented in connection with the figures that come later.

This registration claims the benefit of each of the US Patent Applications with Serial Numbers 61/046594 and 61/046670 filed on April 21, 2008; 61/083957 and 61/083961 filed on July 28, 2008, and 61 / 145.097 filed on January 15, 2009.

BRIEF DESCRIPTION OF THE FIGURES

The figures provided here are not necessarily drawn to scale, some components and elements are enlarged for clarity. Of these: Figures 1A and 1B are views of the lateral section illustrating variants of the braid ball implant in locations of bifurcation and lateral wall aneurysm respectively, in which a folded section in each implant provides a tissue interface nontraumatic; Figure 2 is an enlarged view of the implant depicted in Figure 1B; Figures 3A-3B are perspective side views of a braid ball of folded section in progressively larger sizes; Figures 4A and 4B are views of the side section illustrating variations of the braid ball implant of the proximal fin deployed within the locations of the bifurcation aneurysm; Figure 5A is a side view of a version of the anchored stent of a braid ball implant; Figure 5B is a side view of a stent with a box for receiving a braid ball implant; Figure 6 is a side view illustrating a braid ball implant of folded section in a PVO application; Figure 7 is a side view of the implant section of Figure 6; Figures 8A and 8B are side views of the section of an implant shown in the manufacturing phases; Figure 9 is a side view of the section of an implant in which the folded section is to be used on a proximal side of the device; Figures 10A-10D are side views illustrating the manufacturing phases of a braid ball implant of folded section; Figures 11A and 11B are views from one end that diagrammatically illustrate a technique for presenting the profile of the implant fold; Figures 12A and 12B are side views of the section illustrating folded section braid ball implants with associated tools to fix their shape; Figures 13A and 13B are partial views of the side section illustrating alternative braid / band adhesion methods; Figure 14 is a partial view of the side section illustrating a method of gluing the bushing; Figure 15 is a partial side view showing a method of bushing trimming; Figure 16 is a side view of the section illustrating another variant of the folded section braid ball implant; Figures 17A-17D are side views illustrating the manufacturing phases of the embodiment of Figure 16; Figure 18 is a side view of a variant of the positioning system suitable for use in the present invention; Figure 19A is a partial view of the side section of a distal end of another variant of the positioning system suitable for use in the present invention; Figure 19B is a view from the end from within the implant of the system shown in Figure 19A; Figures 20A-20F are partial perspective views of the implant separation with a system constructed in accordance with the method shown in Figures 19A and 10B; and Figure 21 is a perspective view that provides a summary of a treatment system according to the present invention.

Variants of the invention are contemplated from the embodiments represented. Consequently, the representation of aspects and elements of the invention in the figures is not considered to limit the scope of the invention.

DETAILED DESCRIPTION

Various exemplary embodiments of the invention are described below. Reference is made to these examples in a non-limiting sense. They are provided to illustrate the most widely applicable aspects of the present invention. Various changes can be made to the described invention and equivalent terms can be substituted without departing from the true spirit and scope of the invention. In addition, many modifications can be made to adapt to a given situation, material, composition of the material, process, action or actions or step or steps of the process towards the objective or objectives, spirit or scope of the present invention. All these modifications are intended to be within the scope of the claims made herein.

Returning to Figure 1A, a first implant 20 according to the present invention is shown. It is formed from a tubular braid material comprising an elastic material such as Nitinol that defines an open volume (generally round, spherical, ovular, heart-shaped, etc.) in an uncompressed / constricted state.

The implant 20 is fixed inside a bag 2 of the aneurysm in a vascular bifurcation 4. It is placed through an access through the main vessel 8 (for example, the basilar artery), preferably through a commercially available microcatheter (not shown) with a placement system as detailed below.

The size of the implant can be selected to fill and somehow extend out of the neck 10 of the aneurysm so that the proximal end 22 of the device helps direct blood flow along the surface of the braid from which it is constructed to the secondary vessels 8. A distal end of the ball has a cap shape and adjacent to a fold 24 in the braid, which results in a two-layer construction 26, 28 (inner and outer layers respectively) at less where it is impacted by the flow in the neck 10 of the aneurysm. As shown, one or more turns of the spiral 30 (for example, Pt wire) or a band (not shown) can provide a radiopaque element to mark the implant site.

The fold 24 in the braid is fixed in a more tight radius in the implant 40 shown in Figure 1B. Here, the implant 40 is received inside an aneurysm 12 of a side wall outside a vessel 14. A hub 42 of the implant is in front of the blood coming and directed along the access line and vascular placement.

As seen more easily in Figure 2, the implant 40 includes a ligature 44 that closes an opening 46 defined by the fold. A radiopaque marker 48 (for example Pt) is attached by ligation. Such a marker does not interfere with the compression of the implant for placement. The radiographic visibility of the proximal end of the ball can be achieved due to the density of the braid that comes together, alone, or a radiopaque band 50 (for example Pt) can be added.

Ligation 44 may comprise any biocompatible material that includes Stainless Steel, Titanium, Nitinol (possibly a wire that is martensitic at body temperature - commonly referred to as "muscle wire"), suture, etc. An advantage of using wire is that it can be twisted simply to fix its position, along with the marker. In any case, the ligation filament should be thin (for example, approximately 0.0015 inches (0.4 mm) in diameter or less) if a minimum radius fold is desired.

Another notable element of the implant 40 refers to the hub 42 adjacent to the area. Specifically, a widened or trumpet-shaped recapture profile 52 is fixed in the braid to aid in the recapture of the device inside the placement catheter through which the device is advanced. An access port 54 is disposed within the bushing. This port accepts a placement system interface. The construction of the placement system as well as other optional details of the implant are provided below.

Of course, Figure 2 shows a ball in an unconstrained state. When fixed within an aneurysm, the implant will rather adapt to its shape (for example, as shown in Figure 1A). Generally, the implant will be somewhat oversized to exert a small load on the aneurysm wall to help maintain a stable position of the ball. However, the ball can be deliberately undersized, especially in a side wall application (for example, as shown in Figure 1B) in case it is desired that any element of the bushing be able to rotate with the ball to be dragged With the flow of blood.

Depending on the desired setting, the implant selected by the doctor may rotate outward to have exactly the appropriate size after placement due to the variability of the aneurysm morphology and / or the limitations of medical imaging. That is when the recapture profile is most useful in facilitating implant recovery. The first implant can be discarded in favor of a second with a more appropriate size. Figures 3A-3C illustrate implants 60, 62 and 64 in a gradation of sizes. Naturally, the sizing interval can be varied. Similarly, the shape can be varied.

In the three examples provided it is important that a fixed pore size be maintained towards the center of the ball. It will generally be desirable to minimize the overall pore size. However, the density of the braid that can be achieved in the braid of a given tube or the laminated material of the braid is limited by its diameter and wire size. Consequently, each of the three balls shown is made of a braid that incorporates a different number of wires or "ends." For example, the first implant 62 can be produced from a 72-end material folded back braided on a 6 mm diameter mandrel, the second implant 64 made of a 96-end braid folded back on a mandrel of 8 mm, and the third implant 64 made of a 144-end braid bent backward made on a 10 mm mandrel. Alternatively, larger implants (that is, those approximately 10 mm in diameter) may also be made of a 96-end braid in order to maintain a lower crossing profile. Specifically, a catheter cross profile of 0.027 inches (0.7 mm) can be achieved when using a 96-end braid made of a cable with a diameter of 0.001 inches (0.025 mm). Similarly, at the lower end of the range (for example, around a diameter of 5 mm), a braid of 64 ends can be selected instead to achieve cross profiles of 0.021 inches (0.5 mm).

In any case, the braid filaments are shown in pairs within this implant - one of each layer 26,

28. While braid organization is often more random, double / dual layer construction - on average - results in a higher density that could be achieved with a single layer implant due to density limitations of the braid for a given beginning diameter of the braid.

The implants 70, 72 shown in Figures 4A and 4B, respectively, may also have a double layer construction. In which case, they would share their distal configuration with the previous implants 20/40/60. As shown, they are single-layer devices in which the distal end takes the form of an insert bushing.

74.

In either case, the implants include single proximal end configurations. In addition to a bulbous ball or part 80, each implant includes a fin 76, 78 intended to improve its potential for interruption of blood flow. The flap 76 included in the implant 70 is intended for intraaneurysmal use. To place it as shown, the ball or bulbous part is first placed inside the bag 2 of the aneurysm. Next, that part of the device is compressed while it is still mounted on the pusher 100 to

unfold the fin section on it. After the final placement is achieved as shown in Figure 4A, the pusher blocking member (s) received within the hub 42 are then released. Finally, the pusher is removed into the placement catheter 110. To assist in the method of placement one or more radiopaque elements (such as a band 50 at the proximal end of section 80 of the ball) can be arranged so that the deployment can be visualized at each stage.

The implant in Figure 4B does not require such a complication in placement. Because the fin 78 has a size selected only to fill the aneurysm neck, it can be placed in a straight line. In addition, intermediate radiopaque elements may be convenient for confirming the appropriate adjustment and / or deployment.

As shown, the implant ball and disc variant shown in Figure 4B can only be applied to small neck aneurysms compared to the "acorn" type variant of Figure 4A. Generally, the size of the disk will not be significantly larger than that of the diameter of the main / trunk vessel 6 and that of the bifurcation zone 4. Otherwise, the set of vessels will interfere with the deployment. Thus, the disk can be limited from about 2.5 to about 5 mm in diameter.

While better understood in the context of the manufacturing steps of the implant set forth below, the fin 78 may be formed by a simple washer or plate on which the braid is thermally fixed. Otherwise, the shaping tool may be curved or domed so that the fin 78 better follows the contour of the main body of the implant.

The variant of the flap 76 in Figure 4A will typically be formed by a concave / convex shape in a similar manner. The size of this fin may vary. As shown, its outer size has practically the same diameter of the ball portion 80 of the device. It may be smaller and / or cover a smaller extension of the proximal side of the implant 70. Generally, the fin 70 will cover at least about one third and as much as half of the body 80. In this way, adequate neck covering is best ensured when It is used to treat wide neck aneurysms.

Figure 5A is a side view of a version of an anchored vascular stent of a braid ball implant. The stent 120 is sized to be anchored in the main vessel in the treatment of a terminal aneurysm. Thus, part 122 of the ball can only be sized to fill the neck of the aneurysm instead of its entire volume. Such a method can be especially useful for aneurysms in less regular ways. The device in Figure 5B is used in a similar manner, except that a braid ball implant is inserted and is held by a frame or box 124, then the section of the stent is placed in place.

The frame may comprise a plurality of individual wires 126 fixed to a hub 128 of the stent at a proximal end and to another hub or plate 130 at the distal end. In another variant, the wires that form the frame are cut from the same tube as that of the stent cells and any bushing included. They can end at a distal end inside a bushing, be stressed inside a radiopaque band, welded together, fixed with adhesive, or joined by any other means. In any case, they are typically (though not necessarily) linked to form a closed frame. Also, an open frame is contemplated - especially one in which the wires hook back (that is, proximally) to help "grab" the ball when it is placed.

These devices (that is, those illustrated in Figures 5A and 5B) are placed by normal techniques, except that "anti-skip" / recovery elements can be incorporated into the stent section. Nevertheless, at least one row of cells 132 of the stent is arranged in the stent to effect a minimum level of anchorage; however, no less than five can be used

or more with or without any special anti-skip / placement control elements.

While vascular stents advantageously include three support extensions 134 for the ball or ball housing, they can be used more or less. However, the use of three offers the minimum stable structure available. And where they come together they work very similar to a universal joint to help the ball / frame mounted at the end successfully interface with the aneurysm to be treated.

Figure 6 illustrates a completely different use of the exposed implants. That is, an implant 140 is deployed in a vessel (unlike the adjacent vessel within an aneurysm) to occlude the flow. As mentioned before, for use in PVO the distal end of the ball may include a knot or nozzle 142. In fact, such an element is advantageous in a construction illustrated in Figure 7.

In this view of the side section the braid matrix is shown inverted (or turned outward) in the fold 24. A band 144 is fixed between the inner and outer layers of the braid. The band closes the end and serves as a marker (especially when it comprises Pt). An adhesive compound 146 (for example, LOCTITE 331 or 4014) can be used to fill in any residual lumen within the crease opening. As with the other implants (including those in Figures 4A and 4B), the implant may include a section 52 of the recapture profile at its proximal end, adjacent to the bushing 42. Similarly, it may include a bushing port 54.

Otherwise, both ends of the implant can be closed / plugged in with an adhesive or otherwise. Without an access port of the positioning system, the implant can be placed by means of a simple pusher (as opposed to fully recoverable and / or repositionable). Thus configured, a proximal bushing is not required anyway. In reality, the braid can simply be trimmed and fixed on its profile to join and / or its profile secured by welding, adhesive or otherwise at the proximal end.

Another optional aspect of the invention is illustrated in Figures 8A and 8B. That is, a folded layer implant 140 is first formed without taking measures to minimize the radius of curvature in the fold 24 of the braid. While it can still be used, it may instead be convenient to trim the folded layer to produce a modified 140 ’implant as shown in Figure 8B. By doing this, volume is eliminated, and also in certain cases the implant placement properties are changed as desired. The implant becomes more radially adaptable and capable of adjusting a wider range of aneurysm sizes because the ends 142 of the braid can pass between each other rather than resting on the bottom. In this way, the same implant 140 'can fill a smaller volume without necessarily extending from the neck of the aneurysm as indicated by dotted lines in Figure 8B.

In any case, because the original construction technique that uses a braid tube and folds it back to produce two layers, the layers (now separated) are well paired to foreseeably expand and contract. On the other hand, once any curvature that limits the profile (for example, by cutting, grinding, etc.) has been removed, the layers can be reconnected if the adjustment element described above is not desired. A layer 144 of urethane or other adhesive coating (which advantageously includes a radiopaque powder of Barium or Tantalum) can be used locally to carry out such an action without increasing the placement profile.

In addition, the maintenance of the fold in an implant offers numerous advantages in other circumstances - especially when it is formed in such a way that it minimizes the radius / curvature profile of the wire. That is to say, the implants that include the fold can offer a better integrity of the size and radial force in circumstances in which it is desired, to eliminate any loose fibers at one end of the implant without further processing (such as by the application of a polymer), provide a bag for a marker and / or a ligature to suspend a marker, etc.

On the other hand, it should be recognized that the folded end of the implant will not necessarily be fixed at the distal end of the device. Rather, the folded section 24 can be used at a proximal end as shown in Figure 9. And the opening 46 formed by the folded section (when held by a ring, band or ligature 150) provides an interface of the positioning system. 110. The opposite end of the implant may have an intercalated bushing (for example, as illustrated in Figures 4A and 4B) or terminate at trimmed ends 142 very similar to those shown in Figure 8B (with or without a polymer incorporated) or be configured differently.

In any case, Figures 10A-10D illustrate a method for constructing a folded section implant in which the fold profile has been minimized. As those skilled in the art will appreciate, the elements of the method can be applied to the various implant configurations discussed herein.

In these figures, Figure 10A shows a section of braid 200 linked by a suture 202 on a mandrel

204. The ligature is displaced from where the braid is cut so that, when the braid is inverted as shown in Figure 10B, the outer layer 28 extends past the inner layer 26. A loose fold 210 and the braid develop surrounds the profiling shape 212 of the implant.

In Figure 10C the braid is stretched and fixed by a winding 214 (typically a Pt or Stainless Steel wire) around the shape 212 of the ball. Compression shapes 216, 218 are also shown (fastened by fixing pieces, as indicated by arrows). The shape 216 of the lateral fold compresses the fold to a minimum profile during thermal fixation (for example, for a Nitinol braid at 550 ° C for 5 minutes). In this process, natural ligation 202 (if made of suture) disappears by burning and any impediment to achieve a zero or near zero radius of curvature in the fold is eliminated. Opposite shape 218 may define a section of sharp ridges (for when that end of the ball is to be trimmed and used as the distal end, in a "floating layer" ball as described below, etc.) or form a profile of recapture in the braid.

After such form fixation, an embodiment device 220 is prepared once the internal shape is finally removed as illustrated in Figure 10D. During this process the ends of the braid are forced to open and typically lose the integrity / application of the braid. So that such an action does not adversely affect the integrity of the implant, a "tail" 222 incorporated in the embodiment 220 would be long enough (ie, often about 2 cm or more) to prevent any damage due to the frayed ends of the braid that impact on the intended body 224 of the implant.

If the implant is formed from a braid that includes an oxide layer the embodiment is then recorded and then passivated. However, if the prerecorded wire is used in braiding and for any conformed by

heat made in a bowl with salt, oven in vacuum, or by other equipment to minimize the formation of rust, the realization can simply be subjected to a passivation by nitric acid.

Even in an additional intermediate process it is done in steps. Figure 10E illustrates a way in which a band 50 can be added for bushing formation. Specifically, after linking the outer layer 28 with a spiral 226 the band can be threaded along this section. Without the inner layer underneath, the bonded section 228 fits inside the band 50 so that the band can be sized to fit snugly around both braid layers (and an optional mandrel 230 - whose utility is discussed below) when advancing to a point adjacent to the body 224 of the implant.

As an alternative method to compression forming, in Figures 11A and 11B the fold is presented during profiling to achieve minimum radius curvatures in the braid wire. These figures illustrate a technique for prefixing the shape of the implant fold. In Figure 11A the wedges 240 of an undulating device (for example, available through Machine Solutions, Inc and others) receive the braid 200 that is bent back to define a plurality of curvatures. A mandrel 242 is advantageously fixed within the braid. The mandrel limits the compression of the braid tube, which requires that the radii of curvature fit snugly when the opening 224 formed by the wedges is closed as indicated in Figure 11B. The shape of the fold is fixed by heat and / or a combination of tension and heat. The heat can be applied by an oxyacetylene torch, inside an oven or, advantageously, by passing a current through the mandrel. In another method, a multi-element plate holder or clamp is used in a manner similar to the wedges of the inverter illustrated above.

Thus formed, the general implant can be broadly shaped as described in connection with Figures 10A-10D without the use of suture or compression ligation of 216. Instead, a permanent ligation using a fine wire can be employed. which remains throughout the entire process to close the folded end of the ball. This ligature can be installed simply by reversing the folded braid back to expose the curvatures. Alternatively, it can be treated through and around the folds of the curvature with a needle and tied.

The pretreatment of the fold or the compression forming thereof during thermal fixation of the implant volume is advantageous especially in those cases in which the area adjacent to the fold is going to take the form of a cap. However, when a button can be accepted in the design of the device given its intended use (for example, in PVO), Figures 12A and 12B illustrate another method. Specifically, a hypotube 250 (or other profiled shape that includes a bag) is placed on the braid where the braid is caught between a band 50 and / or the band and the mandrel 204, as shown. In addition, as shown in Figure 12B, a second hypotube 252 (or bag-shaped surface) can make contact with the inflection point 254 to further narrow the braid for precise shape fixation.

Regarding the fixation of the remaining form of the implant or its embodiment 220, Figure 12A illustrates the use of a profiled form 256 of the proximal trumpet to fix a smooth recapture profile. In Figure 12B, the proximal shape 258 sets a very tight or sharp radius. Such a shape may be convenient to achieve greater radial force in the implant due to a greater effort of local curvature.

The implant shown in Figure 12B tries to achieve a better anchorage than that of Figure 12A due to the other noteworthy tongue illustrated in the drawings. That is, the shape 260 of the cylindrical band fixed in the implant along the shape of the device, in other cases ovular, produces edges 262 that interact with the vascular tissue with an increased local effort to improve the anchorage.

Both implants also share a flattened / reduced aspect ratio relative to the spherical ball implants previously shown. Such aspect ratio takes into account a larger oversize to anchor the self-expanding implants in the vessel for a resulting length of the device. This fact is advantageous since the focal length of occlusion is often important in the treatment of neurovascular defects in order to unintentionally block adjacent perforator / secondary vessels in PVO applications.

Whatever the shape of the implant, when a bushing is included to secure the braid filaments, certain adhesion problems must be addressed. The bushing has to be securely attached to the braid and it may be necessary to minimize the length of the element. Figures 13A and 13B are partially laterally sectioned views illustrating alternative methods of adhesion of the braid / band. In Figure 13A, the band 50 is fixed past a cut line of the braid. The resulting small glue 270 provides a surface through which a glue 272 can be applied. Once hardened (for example, by UV application) the adhesive is dragged into the braid and forms an edge 274 on which the web does not You can pass. If a glue is not used, then the braid can be mixed with a laser to also form an interference element of the band. Such a laser application can weld the braid to an inner band 276 if one is used. The laser can be applied in a radial direction around the braid, or axially through the cropped face of the braid.

Especially when using a laser energy an alternative method illustrated in Figure 13B can be used. Here, by applying an axially directed laser energy through the edge of the band (s) and the braid face all of them can be welded together. Even if so welded, the resulting face can be sealed with a 272 polymeric adhesive.

Figure 14 further illustrates another method of bushing fixing. Here, diffusion depends on the penetration of the glue / adhesive through the braid below the band to form a joint. A glue bead 280 is applied to an exposed braid segment 200 adjacent to the band 50. A non-adherent mandrel 230 (for example, PTFE coated) may be located within the braid to precisely define a lumen within the braid impregnated with glue. The lumen advantageously functions as a port of the placement system. Once the adhesive has hardened and the mandrel has been removed, an exactly sized composite wall structure has been achieved.

The adhesive can be applied evenly around the braid by rotating the assembly as indicated. Other methods can also be used. In one of them, a plurality of optional access windows 282 can be included in the web to receive and extend the adhesive. The adhesive is also optionally extended away from the braid 200 by a cardboard or absorbent paper pad 284 (or removed by other means) so that there is not an excess of extending / flowing adhesive used to ensure the lumen coverage of the braid and / or the adhesion of the band 50 does not interfere with the self-expanding action of the implant body 224.

The use of an internal band 276 is also optional. As long as it occupies the space that retains the lumen of the braid and the glue only, the inclusion of an internal band in the bushing assembly 42 may sometimes be convenient for the interface of the separation system.

The use of an attached hypotube 286 is also optional. However, this tube offers a grip or grip on which to compress for later trimming. Especially for such use, a wide-walled tube (for example, approximately 0.005 "(0.13 mm) or greater) may be convenient due to the stability it may offer. As with the band that becomes part of the implant, the hypotube 286 may include one or more access windows 282 for the application of the adhesive.

To trim an embodiment 220 of the implant (however, it is profiled), Figure 15 illustrates a method that coordinates well with the method of adhesion of the bushing illustrated in Figure 14. The attached hypotube is specifically captured in a tool 290 mounted on a slide 292. The lateral adjustment may be arranged in order to align a saw blade 294 (typically a diamond coated wheel of 0.004-0.010 inches (0.1-0.25 mm)) with an intermediate space 296 located between the band and grip 286 of the hypotube. Once aligned (the cutting line can be in the intermediate space, or the band itself can be cut) the implant is trimmed. To aid in handling, the implant may be at least constrained in a sheath 298, as shown. Precision cutting / trimming takes into account a band (trimmed or initially installed) as small as approximately 0.010 inches (0.25 mm) high. A more conservative size (for example, approximately 0.020 inches (0.5 mm) in height) may, however, be convenient to ensure braid capture and robustness of the separation system.

After the cut is made, the length of the bushing can be reduced further by polishing its face. After removal of the mandrel (also the cut in the trimming procedure) and cleaning in an ultrasonic bath, the face of the bushing can be sealed with an adhesive.

Another variant 300 of the implant produced by using any of the cavity punching techniques is illustrated in Figure 16. Figures 17A-17D present a few additional steps unique to this manufacturing.

The implant differs from those discussed above in that it includes a braid layer that is not secured at each end of the device. Rather, the inner layer 26 "floats." Its presence increases the density of the implant, but its fibers adjacent to the hub 42 are not required to bend when the ball is compressed in a sheath for placement and / or recapture. Therefore, a relatively smaller force is required for recapture, even when the braid is curved approximately 90 degrees after exiting the bushing (i.e., without the proximal end of the implant body 224 which includes a recapture profile in the design ).

To produce a ball with the inner ends 302 of the braid near the bushing where the density of the outer braid is the highest and most capable to prevent each of the filaments of the inner layer from peeking through the matrix of The braid is carried out an elegant set of manufacturing steps. Specifically, after starting with an embodiment 220 of the implant as shown in Figure 17A, the outer layer is pulled from the braid or pushed out of the intended body 224 of the implant as shown in Figure 17B. The inner layer of the braid is trimmed as shown in Figure 17C. Wire cutters, scissors or other means can be used. Finally, the outer layer is returned to its original position as shown in Figure 17D and the implant device is subsequently processed.

Such a subsequent process may include the application of a band / punching, trimming and / or binding of the closed fold opening. However, such ligation can be advantageously performed before restoring the position of the outer braid while the fold 24 is exposed according to Figure 17B / 17C.

Whatever the techniques used in its construction, the implants are advantageously mounted on a separable pusher. The positioning system 310 in Figure 18 includes a hub 312 of the hypotube with cut windows 314. The window 312 adjacent to the ball hub is critical, the other simply advantageous. An element 316 of the core (advantageously a Nitinol tape) leaves the proximal window 312 or cut and re-enters the second 314. A flange / bumper 316 attached to the hypotube makes contact at a proximal end of the bushing 50 to push the implant 40. Alternatively, an outer sleeve (not shown) can be arranged that extends along the length of the hypotube to a protection 318 and / or bushing 320 of the positioning system. To allow removal of the implant in the placement catheter (not shown), the core member 316 is applied to the inner surface of the bushing lumen (hidden) to retain the implant.

To allow release, the core member is removed inside the hypotube 310 which cleans each of the windows 312, 314 by pulling on the grip 322. At this point the hypotube can exit port 54 of the bushing by removing the pusher.

Another separable positioning system 330 is illustrated in Figures 19A and 19B. It is a fully coaxial design in which control wires 332 are pulled to release interference from a head 334 mounted on an anchor wire 336 that is otherwise unable to pass through a bushing port or lumen 54. Because the wires are pulled directly and only the position of the anchor wire head ensures interference (clearly illustrated in Figure 19B), minimal effort is required. An EPTFE coating on at least the control wires is also useful.

The control wires 332 can extend to or past the head 334 of the control wire (the previous case illustrated in Figure 19A). Another option is to limit the length of the control wire to that of any inner band 276 or to the total dimension of bushing height 42 (as illustrated in Figure 19B). Note also: Figure 19A shows a gap between a pusher sleeve 338 and the hub 50 of the implant. This representation is for illustrative purposes only.

In any case, each lumen of the pusher sleeve 340 and the lumen / port 52 of the implant bushing are preferably sized so that the wires (the control wires 332 and the anchor wire 336) are received in a closed packing arrangement. In this way the implant and the pusher sleeve serve as a guide that eliminates the loading difficulties associated with the wires that become braided.

or intertwined. Also to load the system, the anchor wire is typically tensioned to a very light degree (before simply sticking it in a handle or using a bypass spring incorporated in the design of the handle) to ensure that any space between the implant and the pusher is closed and remains closed during use.

Figures 20A-20F illustrate a variant of the installation system 330 in use. The distal end of the separation system is shown with part 42 of the implant bushing. Figure 20A shows the interlocking of the applied pusher. Figures 20B-20D illustrate the sequential removal of control wires 332. The anchor wire 336 can also be individually removed as shown in Figure 20E. However, it can instead be removed with sleeve 338 of the separation system. Actually, it can be attached to the sleeve. In addition, it must be recognized that it is not necessary to pull the control wires one at a time. They can be operated together. In any case, the separation of the complete implant is illustrated in Figure 20F.

Finally, Figure 21 presents an overview of a treatment system 340 that includes an implant 342 and the handle 342. One or both may be constructed in accordance with the teachings set forth herein. The handle 342 shown includes three knobs. Two control knobs 344 are connected to the control wires (hidden from view), and the third control knob 346 to an anchor wire (hidden from view). A detachable locking cap 348 may be included in the handle design as well as a protective housing section 350. The axis 338 of the catheter / pusher may comprise a simple extrusion (for example, PTFE, FEP, PEEK, etc.) or can be constructed by using conventional catheter construction techniques and include a liner, a braid support and a outer wrap (not shown). A loading sheath 352 is typically disposed on the axis of the pusher. Advantageously, the loading sheath is divisible as shown in the model.

After removing the sterile packaging (not shown) the implant is pushed into the loading sheath

350. The loading sheath is received inside the catheter bushing in order to be used for implant placement, and the implant is advanced into the catheter. Then, the implant can be advanced to and deployed in a treatment site. Or it can be recovered to exchange it for an implant of another size, or repositioned if desired before finalizing the separation, as illustrated in Figures 20A-20F.

The exposed methods may include each of the medical activities associated with the positioning and release of the implant. Thus, the methodology implicit to the positioning and deployment of an implant device is part of the description. Such a methodology may include placement and implantation within an aneurysm in the brain, or in a main vessel indicated as an objective for an occlusion, or other applications. In some methods the various actions of introducing the implant into an aneurysm or main vessel are considered.

More particularly, several methods according to the present description imply the way in which the placement system works to reach a treatment site, for example. Other methods refer to the way in which the system is prepared to place an implant, for example by attaching the braid ball to the placement system. Any method set forth herein may be performed in any order of the reported events that is logically possible, as well as in the order of related events or with slight modifications of the events or in the order of the events.

Also, it has been contemplated that any optional element of the variants of the invention described can be exposed and claimed independently, or in combination with one or more of the elements described herein. The reference to a singular element includes the possibility of a plurality of the same elements present. More specifically, as used herein and in the appended claims, the singular forms "a," "one," "said," and "the" include plural references unless specifically stated otherwise. In other words, the use of the articles considers "at least one" of the element set forth in the previous description as well as the subsequent claims. It has subsequently been observed that a draft of the claims can be drafted in which any optional element is excluded. Thus, this exhibition is intended to serve as a background for the use of an exclusive terminology such as "only", "only" and the like in connection with the recitation of the elements of the claim, or the use of a limitation " negative".

Without the use of such exclusive terminology, the term "comprising" in the claims considers the inclusion of any additional element regardless of whether a given number of elements are listed in the claim or the addition of an element could be considered as transforming the nature of an element set forth in the claims. Except as specifically defined herein, all the technical and scientific terms used herein are given in a sense as widely understood as the validity of the claim is maintained.

The scope of the present invention is not limited to the examples set forth and / or to the specification set forth, but rather only by the scope set forth in the claim. Rather, it should be recognized that the "invention" includes the many variants explicitly or implicitly described herein that include variants that would be obvious to those with an ordinary specialization in the art after reading the present specification. Furthermore, it is not intended that any section of this specification (for example, the detailed description, the summary, the field of the invention) has a special meaning in the description of the invention with respect to another of the claims. Although the foregoing invention has been described in detail for purposes of clarity of understanding, it has been considered that certain modifications may be made within the scope of the claims.

Claims (5)

1. A detachable implant pusher system (330) comprising: an implant (10, 40, 60, 62, 64, 70, 72, 140, 300, 342) that includes a proximal port section (276); an elongated pusher sleeve (338); Y 5 a plurality of elongate members (332, 336) received within a light of the pusher sleeve, which exits at proximal and distal ends, and elongated members are received through the implant port, where the sleeve is blocked to the implant until at least one elongated member is taken inside the sleeve; characterized in that one of the elongate members (336) includes an end of the extended terminal located outside 10 of the port section; and wherein the other elongated member (332) includes an enlarged end.

2.

 The system of claim 1, wherein the enlarged end has a shape selected from the ball and cylinder shapes.

3.

 The system of claim 1, wherein three elongated members are received within the port.

The system of claim 1, wherein the elongate members are received within the lumen of the sleeve in a closed packing configuration.

5.

 The system of claim 1, wherein the elongate member is connected to a handle actuator.

6.

The system of claim 1, wherein the plurality of elongated members provides mechanical interference in the port.